E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Opioid-Dependent Subjects |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10013663 |
E.1.2 | Term | Drug dependence |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to demonstrate that Suboxone is not inferior to Subutex as measured by response rate by the Day 7 Visit. The response rate will be assessed by determining the proportion of subjects in each group who do not receive a dose increase during the double-blind and double-dummy phase. |
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E.2.2 | Secondary objectives of the trial |
This study has eight secondary objectives, which will permit assessment of the overall clinical response to Subutex or Suboxone by comparing the response of subjects switched to Suboxone with that of subjects who remain on Subutex on the following measures: 1. Illicit opioid and non-opioid use as measured by UDS. 2. Illicit opioid and non-opioid drug use as measured by self-report on the Substance Use Inventory (SUI). 3. Self-reported opioid withdrawal symptoms as measured by the Subjective Opiate Withdrawal Scale (SOWS). 4. Addiction-related problem profiles as measured by the Addiction Severity Index (ASI)-Lite. 5. Compliance rate. 6. Treatment retention (ie, subjects who visit the study setting according the study schedule). 7. Time to dose increase as measured by number of days until a dose increase was received |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must satisfy the following criteria before being enrolled into the study: 1. Subjects must be males or non-pregnant, non-lactating females. 2. Subjects must be at least 15 years of age, of either sex, and any race. 3. Subjects (and/or the parent or guardian for subjects under the age of legal consent or who otherwise are unable to provide independent consent) must demonstrate willingness to participate in the study and to adhere to dose and visit schedules. 4. Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria(18) for opioid dependence. 5. Subjects must have been receiving maintenance treatment with Subutex at doses ranging from 4 mg to the maximum dose permitted by country labeling requirements, but not to exceed 24 mg/day, for at least 1 month prior to screening. 6. Subjects must not, according to self-report, have injected opioids more than four times in the month prior to screening. 7. Subjects must have an opioid-negative UDS result prior to randomization. 8. Each subject must confirm that he or she is practicing adequate contraception. Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or must be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who have been postmenopausal for ≥1 year (ie, women who have experienced 12 or more consecutive months of amenorrhea) will be exempted from the requirement to use contraception during the study. Acceptable methods of contraception include condoms (male and female) with or without a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device, oral or injectable hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation). 9. Female subjects of childbearing potential must have a negative urine beta human chorionic gonadotropin (β-hCG) test prior to enrollment in the study. |
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E.4 | Principal exclusion criteria |
A subject who meets any of the following exclusion criteria will be disqualified from participation in the study: 1. Subjects for whom treatment with either Subutex or Suboxone as required in the protocol would be inconsistent with national labeling. 2. Subjects who are unwilling or unable to comply with the requirements of the protocol (eg, pending incarceration) or are in a situation or condition that, in the opinion of the investigator, may interfere with participation in the study. 3. Subjects who are participating in any other clinical study in which medication(s) are being delivered. 4. Subjects with known allergy or sensitivity to naloxone. 5. Subjects who are on the staff, affiliated with, or a family member of the staff personnel directly involved with this study. 6. Subjects must not have serious untreated Axis I DSM-IV-TR psychiatric comorbidity (eg, those who are actively suicidal or homicidal, have untreated schizophrenia, etc). Polysubstance abuse or dependence will not exclude subjects except in the case of unauthorized and significant benzodiazepine use requiring medical detoxification or alcohol dependence requiring medical detoxification. 7. HIV-positive subjects with clinical acquired immunodeficiency syndrome (AIDS). 8. Subjects treated with generic buprenorphine. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The response rate will be assessed by determining the proportion of subjects in each group who do not receive a dose increase during the double-blind and double-dummy phase. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |